Earlier this year, I mentioned we are planning events aimed at helping applicants submit that all elusive “ideal” data package and reduce deficiencies during assessment, to reduce the number of ‘Notification With Grounds’ (NWG) letters generated. We can now announce …

A batch-specific variation is a variation application to request agreement for a single or small number of batches of product to be released outside of the usual conditions of the marketing authorisation. Every year we receive more than 200 batch …